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    Sr Argus Systems Specialist

    Syneos Health
    3+ years
    Not Disclosed
    Croatia
    10 Nov. 26, 2024
    Job Description
    Job Type: Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Senior Safety & Pharmacovigilance (PV) Operations Specialist
    Syneos Health®

    About Syneos Health®
    Syneos Health is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market realities, keeping the customer and patient at the center of everything we do. Our goal is to simplify and streamline operations, making Syneos Health easier to work with and for, while driving the delivery of therapies to change lives.

    With 29,000 employees across 110 countries, WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health
    We are dedicated to developing our people by providing opportunities for career progression, engaging line management, technical training, peer recognition, and a robust rewards program. Our Total Self culture encourages you to be authentically yourself, creating an inclusive work environment where everyone belongs. We embrace diversity of thoughts, backgrounds, and perspectives, making Syneos Health a place where we can all thrive.

    Key Responsibilities:

    General:

    • Develop and maintain a repository of project-related documents (e.g., training, safety and pharmacovigilance reports, proposals, audit lists).
    • Create and update job aids and process documentation.
    • Stay current on FDA/EU/ICH guidelines for safety and pharmacovigilance reporting.
    • Collaborate with SPVG teams to ensure accurate recognition of annual revenue targets.
    • Provide regular updates on SPVG metrics.
    • Perform other assigned duties as needed (up to 15% travel).

    Technology & Safety Systems:

    • Administer, configure, and maintain the Argus Safety database, ensuring sponsor-specific needs are met.
    • Participate in audits, system demos, and the implementation/validation of safety systems.
    • Assist in the development and maintenance of departmental SOPs and Work Instructions.
    • Troubleshoot and resolve issues related to Argus and other safety systems.
    • Generate and quality-check safety reports and queries for internal, client, or regulatory use.
    • Assist with the development and validation of custom reports.
    • Mentor junior Safety Application Specialists and assist with training efforts.
    • Ensure compliance with global drug/biologic/device regulations, GCP, ICH guidelines, and drug development processes.

    Qualifications:

    Required:

    • Bachelor's degree in life science, nursing, pharmacy, computer science, or a related technical field, or equivalent education/experience.
    • Experience with safety database systems and moderate knowledge of medical terminology.
    • Strong background in clinical research, data collection, or computer systems.
    • Advanced computer skills, including experience with relational databases and tools like Oracle Insight/Analytics, Crystal Reports/Business Objects, and SQL Plus.
    • Proficiency in Microsoft Office Suite and email tools.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage multiple tasks and projects, with strong organizational skills.
    • High attention to detail, ensuring accuracy and meeting deadlines.

    Preferred:

    • Familiarity with safety databases like ArisG, Clintrace, or Sponsor Argus.
    • Experience with business intelligence tools (e.g., Business Objects).
    • Mentoring or training experience.

    About Syneos Health:

    We’ve helped support 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and contributed to over 200 studies across 73,000 sites, involving over 675,000 trial patients. At Syneos Health, no matter your role, you’ll take the initiative and challenge the status quo in a dynamic, competitive environment.

    Note: This job description is not exhaustive and may be subject to change as needed.

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